What is the IEC 60601-1 standard?

What is the IEC 60601-1 standard?

IEC 60601-1 (Edition 3.2) deals with the basic safety and essential performance requirements of medical electrical equipment and serves to ensure that no single electrical, mechanical or functional failure shall pose an unacceptable risk to patients and/or operators.

Is IEC 60601 mandatory?

60601 is a widely accepted benchmark for medical electrical equipment and compliance with IEC60601-1 has become a requirement for the commercialisation of electrical medical equipment in many countries. Many companies view compliance with IEC 60601-1 as a requirement for most markets.

What is ME equipment in 60601?

The IEC 60601-1 Standard itself states, “This… Standard applies to… MEDICAL ELECTRICAL EQUIPMENT and MEDICAL ELECTRICAL SYSTEMS… referred to as ME EQUIPMENT and ME SYSTEMS.”

What is IEC testing?

IEC stands for International Electrotechnical Commission. IEC testing brings together the agreed-upon set of rules, specifications, and terminology that allow manufacturers to have their devices tested for conformity.

What is medical electrical equipment?

The IEC 60601 standard defines medical electrical equipment as “equipment provided with no more than one connection to a particular supply mains and intended to diagnose, treat, or monitor a patient under medical supervision and, which makes physical or electrical contact with the patient and/or transfers energy to or …

Can a medical device have no essential performance?

e) Are there devices without essential performance characteristics? It is, indeed, generally possible to develop medical devices without essential performance characteristics because a fault in them does not lead to unacceptable risks.

What standards apply to medical devices?

Most Common Standards for Medical Devices and IVDs

• ISO 13485, which is the standard for medical device quality management systems.
• ISO 14971, which is the standard for medical device risk management.
• ISO 9001, which is the standard for business quality management systems, and the most current version is ISO 9001:2015.

What is EN certified?

European Standards (abbreviated EN, from the German name Europäische Norm (“European Norm”)) are technical standards drafted and maintained by CEN (European Committee for Standardization), CENELEC (European Committee for Electrotechnical Standardization) and ETSI (European Telecommunications Standards Institute).